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Completed

NCT Number: NCT01094483

A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin

The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.

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Key information

Conditions

Platelet Inhibition

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable without clinically significant disease

Exclusion criteria

  • Use of NSAID within 2 weeks
  • Type 1 or 2 DM
  • GI disorder

Treatment and study plan

PN400

Drug

naproxen 500 mg/esomeprazole 20 mg oral tablet

ASA

Drug

Asprin 81 mg enteric coated tablet

Other names: Asprin

Placebo

Drug

Primary outcomes

  1. Pharmacodynamic: Mean percent inhibition of serum thromboxane B2

    Time frame: measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2

  2. Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events

    Time frame: during approx 6 week study period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • POZEN

Registry information

Official study title

A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN 400 and Low Dose Aspirin

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 29, 2010
Registry last updated
Dec 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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